Infectious Disease

FDA grants EUA for COVID-19 antiviral drug molnupiravir. from Merck

December 23, 2021

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Press release

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Healio was unable to confirm relevant financial information at the time of publication.

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The FDA has granted emergency approval for molnupiravir – now the second oral antiviral treatment available for COVID-19.

The drug is approved for the treatment of mild to moderate COVID-19 in adults who test positive for SARS-CoV-2 and are at high risk of progression to severe disease. It’s not approved for use in patients under the age of 18 because it can affect bone and cartilage growth, the agency said.

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The FDA’s Advisory Committee on Antimicrobial Drugs on November 30, in a split vote between 13-10, approved a recommendation to issue an EEA. The recommendation extended to people with COVID-19 who are at high risk of developing serious illness.

“The EEA for molnupiravir is a sign of progress as it ushers in an era of oral antiviral drugs that can be used by those at increased risk for serious illness (elderly and / or immunocompromised patients) when SARS-CoV-2 is first diagnosed will“, Kenneth H. Mayer, MD, the medical research director of Fenway Health and co-director of the Fenway Institute, said Healio. “This can be similar to how drugs like Tamiflu are used on patients who develop the flu.”

On Wednesday, the FDA issued an EUA for Pfizer’s Paxlovid, an antiviral that has also been developed to treat adults at risk for severe COVID-19, but also to treat pediatric patients 12 years of age and older who weigh at least 40 kg or about 88 pounds.

Molnupiravir, developed by Merck in partnership with Ridgeback Biotherapeutics, has Phase 3 data to reduce the risk of hospitalization or death from COVID-19 in high-risk patients. Merck and Ridgeback Biotherapeutics submitted an EUA application on October 11th. Since then, Merck has started manufacturing capsule pills containing molnupiravir. The company expects 10 million treatment courses to be produced by the end of the year. With the EUA, the drug can be available to patients within weeks.

“We hope that by developing an effective oral COVID-19 antiviral drug, pending regulatory discussions, we can have a meaningful impact on the pandemic,” a Merck spokesman told Healio.

The drug’s approval was supported by a double-blind, randomized, placebo-controlled phase 3 study called MOVe-OUT. The study included patients aged 18 and over with a chronic disease or an increased risk of SARS-CoV-2 infection who had not received a vaccine. Of the 709 participants who received molnupiravir, 6.8% were hospitalized or died within a month, compared with 9.7% of the 699 who received placebo. The study results, published in the New England Journal of Medicine, showed that the rate of hospitalizations or deaths up to day 29 was approximately 31% lower with molnupiravir than with placebo (HR = 0.69; 95% CI 0.48 to 1.01).

In comparison, Pfizer’s investigational oral antiviral drug, Paxlovid, reduced the risk of COVID-19-related hospitalization and death by nearly 90% in patients who received the antiviral within days of symptoms, Healio previously reported.

Of the participants who received molnupiravir, one died during the follow-up period compared to nine who received a placebo. Side effects included diarrhea, nausea, and dizziness, according to the FDA.

The drug’s safety and effectiveness will continue to be evaluated, the agency said.

Relation:

Bernal AJ et al. N Engl J Med. 2021; doi: 10.1056 / NEJMoa2116044.

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